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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02058160
Other study ID # EFC12405
Secondary ID 2013-003132-79U1
Status Completed
Phase Phase 3
First received February 6, 2014
Last updated July 1, 2016
Start date January 2014
Est. completion date July 2015

Study information

Verified date July 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes


Description:

Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.


Recruitment information / eligibility

Status Completed
Enrollment 736
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria :

- Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.

- Treatment with basal insulin for at least 6 months before the screening visit.

- Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.

- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.

- For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:

- metformin (more than or equal to1500mg/day or maximal tolerated dose),

- a sulfonylurea

- a glinide,

- a dipeptidyl-peptidase-4 inhibitor

- a sodium glucose co-transporter 2 inhibitor

- Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit,

- Signed written informed consent.

Exclusion criteria:

- Age under legal age of adulthood at screening visit

- HbA1c at screening visit less than 7.5% or above 10%.

- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.

- Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.

- Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (=10 days) due to intercurrent illness is allowed.

- History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.

- Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide.

- Use of weight loss drugs within 3 months prior to screening visit.

- Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.

- History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.

- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).

- Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit

- At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m²

- At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range,

- At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN

- At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L)

- Any contraindication to metformin use, according to local labeling, if the patient is taking metformin.

- Patient who has a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for patients, not treated with metformin.

Exclusion criteria for randomization:

- HbA1c less than 7% or above 10% .

- Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the self-measurements for 7 days the week before randomization visit is above 140 mg/dL (7.8 mmol/L).

- Average insulin glargine daily dose less than 20 Units or above 50 Units ( in the week before randomization visit).

- Amylase and/or lipase more than 3 ULN .

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Insulin glargine/lixisenatide (HOE901/AVE0010)
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
Insulin glargine (HOE901)
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
Metformin
Pharmaceutical form:tablet Route of administration: oral administration

Locations

Country Name City State
Australia Investigational Site Number 036505 Box Hill
Australia Investigational Site Number 036501 Heidelberg
Australia Investigational Site Number 036504 Parkville
Canada Investigational Site Number 124504 Beamsville
Canada Investigational Site Number 124512 Brampton
Canada Investigational Site Number 124502 Guelph
Canada Investigational Site Number 124507 Kelowna
Canada Investigational Site Number 124505 Montreal
Canada Investigational Site Number 124511 Oakville
Canada Investigational Site Number 124509 St-Romuald
Canada Investigational Site Number 124503 Toronto
Canada Investigational Site Number 124510 Toronto
Canada Investigational Site Number 124501 Vancouver
Canada Investigational Site Number 124508 Victoria
Chile Investigational Site Number 152511 Puerto Varas
Chile Investigational Site Number 152501 Santiago
Chile Investigational Site Number 152502 Santiago
Chile Investigational Site Number 152503 Santiago
Chile Investigational Site Number 152507 Santiago
Chile Investigational Site Number 152514 Santiago
Chile Investigational Site Number 152509 Talagante
Chile Investigational Site Number 152513 Temuco
Chile Investigational Site Number 152504 Vina Del Mar
Czech Republic Investigational Site Number 203502 Cheb
Czech Republic Investigational Site Number 203504 Hranice
Czech Republic Investigational Site Number 203507 Krnov
Czech Republic Investigational Site Number 203506 Liberec
Czech Republic Investigational Site Number 203503 Olomouc
Czech Republic Investigational Site Number 203514 Plzen
Czech Republic Investigational Site Number 203515 Plzen
Czech Republic Investigational Site Number 203511 Praha 4
Czech Republic Investigational Site Number 203508 Praha 5
Czech Republic Investigational Site Number 203509 Praha 8
Czech Republic Investigational Site Number 203505 Prostejov
Denmark Investigational Site Number 208503 Aarhus C
Denmark Investigational Site Number 208509 Horsens
Denmark Investigational Site Number 208501 København Nv
Denmark Investigational Site Number 208505 København S
Denmark Investigational Site Number 208502 Kolding
Denmark Investigational Site Number 208504 Viborg
Estonia Investigational Site Number 233502 Pärnu
Estonia Investigational Site Number 233503 Tallinn
Estonia Investigational Site Number 233501 Tartu
Hungary Investigational Site Number 348501 Budapest
Hungary Investigational Site Number 348503 Budapest
Hungary Investigational Site Number 348505 Budapest
Hungary Investigational Site Number 348502 Debrecen
Hungary Investigational Site Number 348506 Kaposvár
Hungary Investigational Site Number 348504 Pápa
Lithuania Investigational Site Number 440501 Kaunas
Lithuania Investigational Site Number 440503 Kaunas
Lithuania Investigational Site Number 440505 Kedainiai
Lithuania Investigational Site Number 440504 Klaipeda
Lithuania Investigational Site Number 440502 Vilnius
Mexico Investigational Site Number 484508 Celaya
Mexico Investigational Site Number 484501 Cuernavaca
Mexico Investigational Site Number 484503 Guadalajara
Mexico Investigational Site Number 484504 Guadalajara
Mexico Investigational Site Number 484506 Guadalajara
Mexico Investigational Site Number 484509 México
Mexico Investigational Site Number 484507 Pachuca
Mexico Investigational Site Number 484505 Puebla
Netherlands Investigational Site Number 528505 Almere
Poland Investigational Site Number 616502 Bialystok
Poland Investigational Site Number 616505 Krakow
Poland Investigational Site Number 616506 Krakow
Poland Investigational Site Number 616507 Plock
Poland Investigational Site Number 616504 Szczecin
Poland Investigational Site Number 616501 Warszawa
Poland Investigational Site Number 616503 Warszawa
Romania Investigational Site Number 642507 Brasov
Romania Investigational Site Number 642510 Bucharest
Romania Investigational Site Number 642508 Bucuresti
Romania Investigational Site Number 642509 Bucuresti
Romania Investigational Site Number 642506 Hunedoara
Romania Investigational Site Number 642505 Iasi
Romania Investigational Site Number 642502 Oradea
Romania Investigational Site Number 642511 Sibiu
Romania Investigational Site Number 642501 Targu Mures
Romania Investigational Site Number 642503 Timisoara
Romania Investigational Site Number 642504 Timisoara
Russian Federation Investigational Site Number 643511 Arkhangelsk
Russian Federation Investigational Site Number 643512 Moscow
Russian Federation Investigational Site Number 643508 Penza
Russian Federation Investigational Site Number 643501 Saint-Petersburg
Russian Federation Investigational Site Number 643513 Samara
Russian Federation Investigational Site Number 643507 Saratov
Russian Federation Investigational Site Number 643514 Saratov
Russian Federation Investigational Site Number 643502 St-Petersburg
Russian Federation Investigational Site Number 643503 St-Petersburg
Russian Federation Investigational Site Number 643504 St-Petersburg
Russian Federation Investigational Site Number 643506 St-Petersburg
Russian Federation Investigational Site Number 643505 St. Petersburg
Russian Federation Investigational Site Number 643509 Voronezh
Slovakia Investigational Site Number 703505 Bratislava
Slovakia Investigational Site Number 703507 Bytca
Slovakia Investigational Site Number 703502 Kosice
Slovakia Investigational Site Number 703510 Kosice
Slovakia Investigational Site Number 703512 Kosice
Slovakia Investigational Site Number 703511 Lubochna
Slovakia Investigational Site Number 703508 Moldava Nad Bodvou
Slovakia Investigational Site Number 703504 Nove Mesto Nad Vahom
Slovakia Investigational Site Number 703509 Nove Zamky
Slovakia Investigational Site Number 703513 Trnava
Slovakia Investigational Site Number 703501 Zilina
Spain Investigational Site Number 724509 Alicante
Spain Investigational Site Number 724506 Alzira
Spain Investigational Site Number 724504 Barcelona
Spain Investigational Site Number 724510 Barcelona
Spain Investigational Site Number 724505 Cáceres
Spain Investigational Site Number 724503 El Ferrol
Spain Investigational Site Number 724508 La Coruña
Spain Investigational Site Number 724501 Sabadell
Spain Investigational Site Number 724507 Segovia
Spain Investigational Site Number 724502 Valencia
Sweden Investigational Site Number 752501 Ljungby
Sweden Investigational Site Number 752503 Malmö
Sweden Investigational Site Number 752504 Rättvik
Sweden Investigational Site Number 752506 Stenungssund
Sweden Investigational Site Number 752505 Stockholm
Sweden Investigational Site Number 752502 Vällingby
Ukraine Investigational Site Number 804501 Chernivtsi
Ukraine Investigational Site Number 804507 Kyiv
Ukraine Investigational Site Number 804510 Kyiv
Ukraine Investigational Site Number 804511 Kyiv
Ukraine Investigational Site Number 804513 Lviv
Ukraine Investigational Site Number 804502 Vinnytsya
Ukraine Investigational Site Number 804508 Vinnytsya
United States Investigational Site Number 840576 Albuquerque New Mexico
United States Investigational Site Number 840605 Amarillo Texas
United States Investigational Site Number 840580 Arlington Heights Illinois
United States Investigational Site Number 840594 Atlanta Georgia
United States Investigational Site Number 840582 Aurora Colorado
United States Investigational Site Number 840553 Austin Texas
United States Investigational Site Number 840598 Austin Texas
United States Investigational Site Number 840543 Avon Indiana
United States Investigational Site Number 840520 Baltimore Maryland
United States Investigational Site Number 840560 Baltimore Maryland
United States Investigational Site Number 840568 Bell Gardens California
United States Investigational Site Number 840607 Birmingham Alabama
United States Investigational Site Number 840613 Burlington Vermont
United States Investigational Site Number 840558 Butte Montana
United States Investigational Site Number 840622 Charleston South Carolina
United States Investigational Site Number 840504 Chesapeake Virginia
United States Investigational Site Number 840519 Chicago Illinois
United States Investigational Site Number 840612 Chicago Illinois
United States Investigational Site Number 840550 Chino California
United States Investigational Site Number 840529 Chula Vista California
United States Investigational Site Number 840579 Columbus Ohio
United States Investigational Site Number 840614 Columbus Georgia
United States Investigational Site Number 840623 Corona California
United States Investigational Site Number 840502 Corpus Christi Texas
United States Investigational Site Number 840530 Dallas Texas
United States Investigational Site Number 840545 Dallas Texas
United States Investigational Site Number 840547 Dallas Texas
United States Investigational Site Number 840586 Dallas Texas
United States Investigational Site Number 840601 Dallas Texas
United States Investigational Site Number 840524 Dayton Ohio
United States Investigational Site Number 840505 Dearborn Michigan
United States Investigational Site Number 840509 Denver Colorado
United States Investigational Site Number 840512 Draper Utah
United States Investigational Site Number 840541 Durham North Carolina
United States Investigational Site Number 840554 Edinburg Texas
United States Investigational Site Number 840618 Eugene Oregon
United States Investigational Site Number 840565 Evansville Indiana
United States Investigational Site Number 840585 Evansville Indiana
United States Investigational Site Number 840615 Evansville Indiana
United States Investigational Site Number 840571 Federal Way Washington
United States Investigational Site Number 840575 Flint Michigan
United States Investigational Site Number 840566 Fresno California
United States Investigational Site Number 840552 Greenbrae California
United States Investigational Site Number 840604 Greenville North Carolina
United States Investigational Site Number 840600 Henderson Nevada
United States Investigational Site Number 840540 Hickory North Carolina
United States Investigational Site Number 840544 Houston Texas
United States Investigational Site Number 840514 Hurst Texas
United States Investigational Site Number 840588 Idaho Falls Idaho
United States Investigational Site Number 840507 Indianapolis Indiana
United States Investigational Site Number 840563 Indianapolis Indiana
United States Investigational Site Number 840583 Jamaica New York
United States Investigational Site Number 840578 Lancaster California
United States Investigational Site Number 840532 Las Vegas Nevada
United States Investigational Site Number 840599 Las Vegas Nevada
United States Investigational Site Number 840501 Lawrenceville Georgia
United States Investigational Site Number 840595 Lewiston Maine
United States Investigational Site Number 840517 Little Rock Arkansas
United States Investigational Site Number 840537 Little Rock Arkansas
United States Investigational Site Number 840581 Los Angeles California
United States Investigational Site Number 840626 Los Angeles California
United States Investigational Site Number 840516 Louisville Kentucky
United States Investigational Site Number 840503 Maumee Ohio
United States Investigational Site Number 840510 Miami Florida
United States Investigational Site Number 840546 Milwaukee Wisconsin
United States Investigational Site Number 840564 Minneapolis Minnesota
United States Investigational Site Number 840621 Mission Viejo California
United States Investigational Site Number 840513 Morehead City North Carolina
United States Investigational Site Number 840591 Murray Utah
United States Investigational Site Number 840617 N Richland Hill Texas
United States Investigational Site Number 840539 Nashua New Hampshire
United States Investigational Site Number 840531 New Hyde Park New York
United States Investigational Site Number 840521 New Port Richey Florida
United States Investigational Site Number 840561 Norfolk Virginia
United States Investigational Site Number 840625 Norfolk Virginia
United States Investigational Site Number 840511 Northridge California
United States Investigational Site Number 840602 Ocala Florida
United States Investigational Site Number 840538 Ocoee Florida
United States Investigational Site Number 840526 Ogden Utah
United States Investigational Site Number 840506 Omaha Nebraska
United States Investigational Site Number 840597 Orem Utah
United States Investigational Site Number 840534 Palm Harbor Florida
United States Investigational Site Number 840573 Palm Springs California
United States Investigational Site Number 840610 Philadelphia Pennsylvania
United States Investigational Site Number 840559 Port Hueneme California
United States Investigational Site Number 840611 Rapid City South Dakota
United States Investigational Site Number 840606 Richmond Virginia
United States Investigational Site Number 840522 Rockville Maryland
United States Investigational Site Number 840525 Roswell Georgia
United States Investigational Site Number 840608 Salem Virginia
United States Investigational Site Number 840592 Salisbury North Carolina
United States Investigational Site Number 840590 Salt Lake City Utah
United States Investigational Site Number 840536 San Ramon California
United States Investigational Site Number 840567 Santa Ana California
United States Investigational Site Number 840551 Smithfield Pennsylvania
United States Investigational Site Number 840593 Spokane Washington
United States Investigational Site Number 840556 Springfield Illinois
United States Investigational Site Number 840570 Sun City Arizona
United States Investigational Site Number 840557 Syracuse New York
United States Investigational Site Number 840609 Tacoma Washington
United States Investigational Site Number 840569 Tarzana California
United States Investigational Site Number 840562 Tempe Arizona
United States Investigational Site Number 840584 Tipton Pennsylvania
United States Investigational Site Number 840577 Tucson Arizona
United States Investigational Site Number 840572 West Hills California
United States Investigational Site Number 840535 Wilmington North Carolina
United States Investigational Site Number 840549 Wilmington Delaware
United States Investigational Site Number 840515 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Czech Republic,  Denmark,  Estonia,  Hungary,  Lithuania,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c from baseline week 30 No
Secondary Percentage of patients reaching HbA1c targets week 30 No
Secondary Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline to week 30 week 30 No
Secondary Change in body weight from baseline week 30 No
Secondary Change in 7-point Self-Monitoring Plasma Glucose profiles from baseline week 30 No
Secondary Change in daily dose of insulin glargine from baseline week 30 No
Secondary Change in Fasting Plasma Glucose from baseline week 30 No
Secondary Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia 30 weeks Yes
Secondary Severe symptomatic hypoglycemia 30 weeks Yes
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